Alleviating Trunk Low Back Pain, With an Active Medical Device Study (ATLAS)
NCT03801941 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2022-03-02
Summary
The aim of the study is to evaluate the reduction of pain by wearing the ATLAS Medical Device in standardized daily activities for patients with Chronic Low Back Pain.
This is an intervention al non blinded study with a crossover design comparing pain evaluated with an Analogue Visual Scale with and without the ATLAS device during 5 standardized daily activities.
Conditions
- Chronic Low Back Pain
Interventions
- DEVICE
-
wearing ATLAS device during evaluation at 4th day
Wearing the ATLAS device 60 min per day during 5 days and evaluation of pain during standardized activities with or without ATLAS Device at the 4th or 5th day of a 4 weeks rehabilitation program.
- OTHER
-
wearing ATLAS device during evaluation at 5th day
Wearing the ATLAS device 60 min per day during 5 days and evaluation of pain during standardized activities without ATLAS Device at the 4th or 5th day of a 4 weeks rehabilitation program.
Sponsors & Collaborators
-
Japet Medical Devices
collaborator INDUSTRY -
University Hospital, Lille
lead OTHER
Principal Investigators
-
Vincent Tiffreau, MD,PhD · University Hospital, Lille
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-04-01
- Primary Completion
- 2021-06-30
- Completion
- 2021-06-30
Countries
- France
Study Locations
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